Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extend...
FDA Device Recall #Z-1990-2012 — Class II — June 5, 2012
Recall Summary
| Recall Number | Z-1990-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 5, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | PSC Industries Inc |
| Location | Louisville, KY |
| Product Type | Devices |
| Quantity | 50 units |
Product Description
Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.
Reason for Recall
The carton label for this device has the manufacturer symbol where the expiration date symbol should be. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors for their Button Switch Pen Electrode Electrosurgical /Extendable Pencils.
Distribution Pattern
Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.
Lot / Code Information
Model Number: 75820, Lot Number: 019632
Other Recalls from PSC Industries Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1991-2012 | Class II | Button Switchpens, w/Extendable Needle Electrod... | Jun 5, 2012 |
| Z-1998-2012 | Class II | Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Ins... | Jun 1, 2012 |
| Z-1994-2012 | Class II | Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips N... | Jun 1, 2012 |
| Z-1999-2012 | Class II | Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5... | Jun 1, 2012 |
| Z-1995-2012 | Class II | Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm ... | Jun 1, 2012 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.